Apparatus and methods for treating female urinary incontinence

ABSTRACT

Apparatus and methods are provided for treating female urinary incontinence by applying a form of energy to tissue in the vicinity of the urethra and/or bladder outlet to change tissue compliance without substantially narrowing the urethral and/or bladder outlet lumen. The apparatus comprises an elongated shaft having a means for treating urethral tissue and an expandable member deployable distal of the means for treating. The expandable member is configured to be anchored against the bladder outlet to dispose the means for treating at a desired treatment site in the urethra using only tactile feedback. The means for treating may include a needleless RF electrode, an ultrasound transducer, or a cryogenic probe configured to be advanced through a hollow needle, each of which are designed to reduce or eliminate symptoms associated with urinary incontinence.

REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 10/207,689, filed Jul. 25, 2002, which is acontinuation-in-part of U.S. patent application Ser. No. 09/678,500, nowU.S. Pat. No. 6,470,219, filed Oct. 2, 2000.

FIELD OF THE INVENTION

This invention relates to apparatus and methods for treating urinaryincontinence, and more particularly, for treating female urinaryincontinence in humans by applying a selected form of energy to tissuein the vicinity of the urethra and/or bladder outlet to cause a changein tissue compliance without substantially narrowing the urethral lumenand/or bladder outlet.

BACKGROUND OF THE INVENTION

The term “urinary incontinence” refers to the involuntary leakage ofurine from the body in an uncontrolled manner. One cause of incontinenceis increased mobility of the bladder outlet (bladder outlethypermobility) where the bladder and proximal urethra do not maintaintheir normal anatomic positions during transient periods of increasedbladder pressure due to increased intra-abdominal pressure. In addition,there is a small region of circular muscle surrounding the middleportion of the urethra in the female called the “urethral sphincter,”which also participates in the controlled release of urine from thebladder. If the bladder outlet becomes too mobile and/or if the urinarysphincter or any other part of the urinary system malfunctions, theresult may be urinary incontinence.

Urinary incontinence can generally be characterized into two types, oneof which is called “stress incontinence” and the other “urgeincontinence.” Stress incontinence refers to involuntary loss of urineduring coughing, laughing, sneezing, jogging or other physical activitythat causes a sufficient increase in intra-abdominal pressure. Urgeincontinence refers to the involuntary loss of urine due to unwantedbladder contraction that may be associated with an uncontrollable desireto urinate. “Mixed incontinence” refers to a combination of both urgeand stress incontinence.

Heretofore, many different types of treatment have been utilized totreat female urinary incontinence including surgical and non-surgicalprocedures including the injection, under cystoscopic and/orfluoroscopic visualization, of collagen or other material into thetissue surrounding or adjacent to the bladder outlet and/or proximalurethra. In addition, drug therapy also has been utilized, for example,drugs to treat the detrusor muscle, which is the bladder wall muscleresponsible for contracting and emptying the bladder. All of theseprocedures and therapies have drawbacks, are relatively expensive, andin the case of injections, require the equipment and training necessaryto perform cystoscopic and/or fluoroscopic visualization of the urethraand bladder outlet. There is therefore a need for a new and improvedapparatus and method for treatment of female urinary incontinence.

In view of the drawbacks of previously-known devices, it would bedesirable to provide apparatus and methods for treating female urinaryincontinence using an elongated shaft configured to be introduced viathe urethral orifice and advanced through the urethral lumen to enableenergy delivery to surrounding tissue.

It further would be desirable to provide apparatus and methods fortreating female urinary incontinence that allow a physician to remodelthe urethral wall and/or bladder outlet without the need for avisualization device, e.g., a cystoscope or fluoroscope.

It still further would be desirable to provide apparatus and methods fortreating female urinary incontinence by techniques that do not carryrisks associated with surgical incisions, such as infection andherniation, and do not result in external scarring.

SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the present invention toprovide apparatus and methods for treating female urinary incontinenceusing an elongated shaft configured to be introduced via the urethralorifice and advanced through the urethral lumen to enable energydelivery to surrounding tissue.

It further is an object of the present invention to provide apparatusand methods for treating female urinary incontinence that allow aphysician to remodel the urethral wall and/or bladder outlet without theneed for a visualization device, e.g., a cystoscope or fluoroscope.

It still further is an object of the present invention to provideapparatus and methods for treating female urinary incontinence bytechniques that do not carry risks associated with surgical incisions,such as infection and herniation, and do not result in external scarringor require dressings or bandages.

These and other objects of the present invention are accomplished byproviding apparatus comprising a handle, an elongated shaft having adistal region, an expandable member, and means for treating thesubmucosal layer of the urethral wall and/or bladder outlet to cause achange in tissue compliance without substantially narrowing the urethraland/or bladder outlet lumen.

In a preferred embodiment, the handle is coupled to a proximal end ofthe elongated shaft and is manipulated by the physician to insert thedistal region into a patient's urethra, either individually or using anappropriate introducer sheath. The handle includes an actuator fordeploying the expandable member.

In accordance with one aspect of the present invention, the expandablemember is deployable at a predetermined distance distal of the means fortreating. The expandable member may comprise a balloon or mechanicallyactuated basket that is configured to be moved between a contractedposition, which permits insertion of the expandable member through theurethra and into the patient's bladder, and a deployed position, whereinthe expandable member anchors against the bladder outlet. The expandablemember facilitates tactile alignment of the means for treating at adesired treatment site, without the need for direct visualization.

In one embodiment of the present invention, the means for treatingcomprises at least one needleless electrode embedded in a lateralsurface of the elongated shaft. The needleless electrode is coupled to aradio frequency generator/controller that causes the electrode to reacha desired temperature to heat the urethral tissue. In accordance withprinciples of the present invention, cooling fluid is provided in thevicinity of the electrode to cool the urethral and bladder outlet mucosaduring the provision of RF energy. The application of RF energy causesdenaturation of collagen in small localized areas where treatment isdelivered. Following cessation of energy delivery, these microscopicfoci of denatured collagen renature and heal, ultimately creating minuteareas of decreased tissue compliance without substantial anatomicchange.

In an alternative embodiments of the present invention, the means fortreating comprises an ultrasound transducer disposed on the elongatedshaft. The ultrasound transducer is coupled to an ultrasoundgenerator/controller. Ultrasound beams generated by the transducer maybe focused in accordance with known techniques to cause a rise in tissuetemperature at a desired distance beneath the mucosal layer of theurethra. Collagen denaturation and subsequent renaturation caused by therise in temperature changes the tissue compliance in the vicinity of theurethra and/or bladder outlet without substantial anatomic change.

In a further alternative embodiment of the present invention, the meansfor treating comprises at least one hollow needle having contracted anddeployed states and a cryogenic probe adapted to be inserted through thehollow needle. In the contracted state, the hollow needle is disposedwithin the confines of the elongated shaft, while in the deployed state,the hollow needle extends beyond the elongated shaft to pierce throughurethral tissue and/or bladder outlet mucosa. The cryogenic probe isadvanced through the hollow needle to a treatment site within theurethral tissue to locally freeze tissue and cause necrosis, which inturn causes remodeling of tissue in the vicinity of the urethra and/orbladder outlet.

Methods of using the apparatus of the present invention to inducelocalized areas of decreased tissue compliance, and to reduce oreliminate the effects of urinary incontinence, also are provided.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features of the invention, its nature and various advantageswill be more apparent from the accompanying drawings and the followingdetailed description of the preferred embodiments, in which:

FIGS. 1A-1E are, respectively, side and side sectional views of a deviceto treat urinary incontinence, cross-sectional views along lines A-A andB-B of FIG. 1B, and a schematic view depicting use of apparatus of FIG.1A;

FIGS. 2A-2C are, respectively, a side view of a first embodiment of thepresent invention and side sectional views of alternative means forcooling the mucosa in conjunction with the apparatus of FIG. 2A;

FIG. 3 is a schematic view depicting the use of apparatus of FIG. 2;

FIG. 4 is a side view of an alternative embodiment of the presentinvention;

FIG. 5 is a schematic view depicting the use of apparatus of FIG. 4;

FIGS. 6A-6C are, respectively, a side view of a further alternativeembodiment of the present invention, and cross-sectional views alonglines C-C and D-D of FIG. 6A;

FIG. 7 is a schematic view depicting the use of apparatus of FIG. 6;

FIGS. 8A-8B are side sectional views illustrating the use of analternative expandable member;

FIG. 9 is a side view of a device that allows movement of a means fortreating with respect to an expandable member;

FIGS. 10A-10D are, respectively, a side sectional view of apparatus ofFIG. 9 in a first position, cross-sectional views along line E-E of FIG.10A illustrating two alternative configurations, and a side sectionalview of apparatus of FIG. 9 in a second position; and

FIG. 11 is a side view of a device that allows movement of an expandablemember with respect to a means for treating.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIG. 1, a device to treat urinary incontinence,described in U.S. patent application Ser. No. 09/678,500, which isherein incorporated by reference in its entirety, is shown. Apparatus 20comprises semi-rigid elongated tubular shaft 22 having proximal anddistal extremities 23 and 24, distal region 72, and lumen 26 extendingfrom proximal extremity 23 to distal extremity 24.

Handle 31 has proximal and distal ends, and is configured to be graspedby the human hand. The distal end of handle 31 is coupled to proximalextremity 23 of elongated shaft 22. The proximal end of handle 31preferably comprises rear surface 33 through which electrical connector34 extends. Handle 31 further comprises fluid-in port 36, fluid-out port37 and, optionally, auxiliary port 39.

It will be apparent to those skilled in the art that handle 31 maycomprise any suitable exterior shape that is configured to be grasped bya human hand, and is not intended to be limited by the exterior shapesdepicted herein. An illustrative, alternative handle shape is depictedin commonly-assigned U.S. patent application Ser. No. 10/207,689, whichis herein incorporated by reference in its entirety.

Plurality of needle electrodes 41-44, which are sharpened at theirdistal extremities, are disposed within distal region 72 of elongatedshaft 22 in a contracted state. Needle electrodes 41-44 assume apreformed shape in a deployed state, i.e., when they are no longerconstrained within elongated shaft 22, and preferably comprise ashape-memory material such as a nickel-titanium alloy. In the deployedstate, needle electrodes 41-44 curve outwardly and downwardly to providea fishhook-like configuration, as shown in FIG. 1A. Needle electrodes41-44 are disposed in suitable angular positions, as for example, spacedcircumferentially in a single plane 90° apart. This is accomplished byslideably mounting needle electrodes 41-44 in plurality of PEEK hypotubes 46 in four spaced-apart lumens 47 of Pebax block 48, as shown inFIG. 1D.

Pebax block 48 is mounted in a fixed position in distal region 72 ofelongated shaft 22. Needle electrodes 41-44 extend proximally throughhypo tubes 46 and are mounted in fixed positions in four lumens 49spaced apart in Pebax block 51, as shown in FIG. 1C.

Pebax block 51 is slideably mounted within elongated shaft 22. Rod 53has a distal extremity mounted in a fixed position in centrally disposedlumen 54 of block 51 and extends proximally from block 51 and intorecess 56 of handle 31. Slide block 58 has outwardly extendingprotrusion 59 coupled to rod 53, as shown in FIG. 1B. Knob 57 isslideably mounted on the exterior of handle 31 and is secured toprotrusion 59, e.g., using a screw. Movement of knob 57 longitudinallywith respect to handle 31 causes needle electrodes 41-44 to be movedbetween extended and retracted positions in hypo tubes 46.

Cooling liquid preferably is supplied via elongated shaft 22 so that itis discharged in the vicinity of needle electrodes 41-44 via tubing 61.Tubing 61 is in turn connected to fitting 36. Tubing 62 is connected tofitting 37 and extends distally into lumen 26 of tubular member 22,through block 51, and terminates at block 48, where it is placed incommunication with return lumen 63 in block 48. Tubing 61 continuesthrough block 48 and opens into shaft 66, which extends distally fromblock 48.

Expandable member 55 is disposed on shaft 66 and illustrativelycomprises a balloon. As will be described hereinbelow with respect toFIGS. 8A-8B, expandable member 55 alternatively may comprise amechanically self-deployable basket.

Shaft 66 has openings 60 disposed within expandable member 55. Openings60 are in fluid communication with tubing 61 and are used to inflateexpandable member 55. Expandable member 55 is provided with plurality ofopenings 74 through which the cooling liquid introduced into expandablemember 55 may escape and be discharged in the vicinity of needleelectrodes 41-44 to cool the tissue being treated, as hereinafterdescribed. The cooling liquid, after it has performed its function, isaspirated through central return lumen 63 to fitting 37. Alternatively,openings 74 may be disposed directly in a lateral surface of shaft 22,as depicted by openings 74′ in FIG. 1B.

Fittings 36 and 37 are connected by tubing 75 to irrigationpump/controller 64, as depicted in FIG. 1A. Controller 64 supplies acooling liquid, such as room temperature water, to fitting 36 and mayalso aspirate the liquid through fitting 37 after it has been used.

Plurality of insulated wires 65 are connected to electrical connector 34with slack being provided within handle 31. Electrical connector 34 isadapted to be connected to RF generator/controller 68 by cable 69, asdepicted in FIG. 1A.

Wires 65 extend distally through lumen 26 of elongated shaft 22, throughlumens in blocks 48 and 51, and are coupled to four thermocouple wires(not shown) extending through hollow needles 41-44. The thermocouplewires are connected to thermocouples 67, which are mounted in sharpenedtips of needles 41-44 for measuring needle-tip temperatures, as shown inFIG. 1B.

Referring now to FIG. 1E, a preferred method for treating urinaryincontinence using apparatus 20 is described. Atraumatic tip 71, whichis disposed distal of expandable member 55, is inserted into urethra Uof a patient with expandable member 55 and needles 41-44 being providedin contracted states. Elongated shaft 22 is distally advanced withinurethra U so that expandable member 55 is positioned within bladder B,e.g., using markings 76 of FIG. 1B. Expandable member 55 then isdeployed, e.g., by inflating a balloon via fluid-in port 36. Expandablemember 55 then is retracted proximally so that expandable member 55 isanchored against bladder outlet O, as shown in FIG. 1E.

After expandable member 55 has been seated against bladder outlet O, aphysician distally advances knob 57 with respect to handle 31 to causeneedles 41-44 to be advanced from their retracted positions withindistal region 72 of elongated shaft 22. Needles 41-44 move distally andsidewise beyond the outer cylindrical profile of elongated shaft 22 andinto the urethral tissue in the vicinity of bladder outlet O, as shownin FIG. 1E.

After needles 41-44 have been deployed, radio frequency energy issupplied from RF generator/controller 68. As is well known to thoseskilled in the art, such a generator may be configured to provideimpedance readings that give an indication of whether or not needleelectrodes 41-44 have been properly positioned within the tissue.

Liquid is introduced in the vicinity of needle electrodes 41-44 viairrigation pump/controller 64 and openings 74, as described hereinabove,to cool the mucosal layer of the urethral wall. Radio frequency energythen is supplied to the needle electrodes at a power level ranging from1 to 10 watts for a period of time ranging from 60 to 90 seconds toachieve approximately an 70° C. temperature in the tissue being treated,while the overlying mucosal tissue is preserved by the cooling liquidflow. In accordance with one aspect of the present invention, it isdesirable that the tissue not to reach a temperature of 100° C.Therefore, RF generator 68, utilizing the information supplied fromthermocouples 67, is programmed to automatically turn off if thetemperature reaches a pre-set temperature, e.g., 80° C. Otherwise, forthe duration of the treatment, the RF power is adjusted to maintain thetissue being treated at the desired target temperature.

Once the first RF treatment has been completed, the radio frequencyenergy is turned off and knob 57 is retracted to withdraw needleelectrodes 41-44 into their retracted positions within distal region 72of elongated shaft 22. The device then may be rotated a predeterminedangle, the needles redeployed and another radio frequency energytreatment may be applied to surrounding tissue. During this entireprocedure, irrigation liquid is introduced through openings 74 ofexpandable member 55 and/or openings 74′ of shaft 22. As the irrigationfluid progressively fills the bladder during each RF treatment, thegeometry of the bladder outlet changes as the bladder is filled suchthat repeated seating of the expandable member results in the electrodelocation moving progressively towards the bladder outlet.

In connection with the RF treatments described hereinabove, tiny sitesof collagen in the vicinity of the treatment site renature over theensuing weeks. Such treatment results in changes in tissue compliance ofthe bladder outlet and/or urethral walls to cause a significantimprovement in urinary incontinence.

Referring now to FIGS. 2-3, a first embodiment of the present inventionthat utilizes a plurality of needleless electrodes to treat urinaryincontinence is described. Apparatus 80 comprises elongated shaft 82having proximal and distal ends and distal region 86 disposed adjacentto the distal end. Handle 84 is provided in accordance with handle 31 ofFIG. 1, except as noted below, and is coupled to the proximal end ofelongated shaft 82.

Elongated shaft 82 further comprises at least one needleless electrode90 capable of transmitting radio frequency energy. Needleless electrode90 may comprise a hollow, curved surface, as depicted in FIGS. 2B-2C,and preferably is manufactured from stainless steel. Needlelesselectrode 90 preferably is embedded into a lateral surface of elongatedshaft 82 so that curved regions 107 and 108 of electrode 90 extendwithin an interior portion of elongated shaft 82, while outer surface101 of electrode 90 is disposed outside of and faces away from elongatedshaft 82, as shown in FIGS. 2B-2C.

Elongated shaft 82 further comprises irrigation port 91 and optionalaspiration port 92, which are coupled to irrigation tubing 104 andaspiration tubing 105, respectively. Irrigation tubing 104 andaspiration tubing 105 extend proximally from their respective ports 91and 92, through elongated shaft 82 and handle 84, and are coupled tofluid-in and fluid-out ports 93 and 94, respectively. Fluid-in andfluid-out ports 93 and 94 in turn are coupled to fluid controller 106.

In FIGS. 2A and 2B, irrigation and aspiration ports 91 and 92 areillustratively disposed in a lateral surface of elongated shaft 82adjacent to electrode 90. In an alternative embodiment shown in FIG. 2C,irrigation and aspiration ports 91 and 92 may be omitted and irrigationand aspiration tubing 104 and 105 may be coupled to first and secondcurved ends 107 and 108 of hollow electrode 90, respectively. In thisembodiment, fluid infused into irrigation tubing 104 flows throughhollow electrode 90 to provide a cooling effect upon outer surface 101,then is aspirated through tubing 105.

Apparatus 80 of FIG. 2 further comprises wire 98 and thermocouple wire99, each having proximal and distal ends. The distal ends of wire 98 andthermocouple wire 99 are coupled to needleless electrode 90, as shown inFIGS. 2B-2C, while the proximal ends extend through elongated shaft 82and handle 84. Wire 98 and thermocouple wire 99 preferably are coupledto electrical connector 110 of handle 84, which in turn is connected toRF generator/controller 109 by cable 111.

Apparatus 80 further comprises expandable member 87 that is deployableat a predetermined distance distal of needleless electrode 90.Expandable member 87 may comprise a balloon that is disposed on distalregion 86 or, alternatively, a self-expanding mechanical basket asdescribed hereinbelow with respect to FIGS. 8A-8B.

Referring now to FIG. 3, a preferred method for using apparatus 80 ofFIG. 2A is described. In a first step, atraumatic tip 85 at the distalend of elongated shaft 82 is inserted into a patient's urethra U withexpandable member 87 in a contracted state. Expandable member 87 ispositioned within bladder B, e.g., using measurement indica 96 disposednear the proximal end of elongated shaft 82 (see FIG. 2A). Expandablemember 87 is deployed and handle 84 is retracted proximally so thatexpandable member 87 is anchored against bladder outlet O.

In accordance with the present invention, retracting expandable member87 against bladder outlet O positions needleless electrodes 90 at adesired treatment site within urethra U using only tactile feedback.Once properly positioned, liquid is introduced to irrigation port 91 viairrigation pump 106 to provide a cooling effect to mucosal layer M ofthe urethra. Radio frequency energy then is supplied to needlelesselectrode 90 to achieve a temperature of approximately 70° C. in thetissue being treated, i.e., the submucosal tissue S of the urethralwall. The overlying mucosal tissue M is preserved by the cooling liquidflow. Preferably, the submucosal tissue is not heated to a temperaturesignificantly higher than 70° C. Therefore, RF generator 109, utilizingthe information supplied from thermocouple 97, preferably is programmedto automatically turn off if the temperature reaches a pre-settemperature, as for example, 80° C. Otherwise, for the duration of thetreatment, the RF power is adjusted to maintain the submucosal tissue atthe desired target temperature.

After this first RF treatment has been completed, the radio frequencyenergy is turned off and the device can be advanced into the bladderlumen and rotated a predetermined angle so that needleless electrode 90may contact a new interior surface of urethra U. Once electrode 90 hasbeen rotated to the desired angle, handle 84 is retracted proximally toseat expandable member 87 in bladder outlet O, and RF energy is providedto needleless electrode 90, as described hereinabove. Upon completion ofthe procedure, expandable member 87 is contracted and elongated shaft 82is removed from the patient's urethra.

As described hereinabove with respect to the embodiment of FIGS. 1A-1E,the RF treatments produce collagen denaturation in small, localizedareas where the treatment is delivered, followed by collagenrenaturation and remodeling over the ensuing weeks and months, therebyresulting in changes in tissue compliance within the urethra and/orbladder outlet.

Referring now to FIGS. 4-5, a further alternative embodiment of thepresent invention is described wherein high intensity focused ultrasound(HIFU) is applied to treat urinary incontinence. HIFU involves directinghigh intensity ultrasound waves at the selected tissue to create heat ina precise area and cause coagulation and tissue necrosis.

In FIG. 4, apparatus 120 comprises elongated shaft 121 having proximaland distal ends and distal region 122 disposed adjacent to the distalend. Handle 128 is coupled to the proximal end of elongated shaft 121and may comprise inflation port 137 that is in fluid communication withexpandable member 123, illustratively a balloon. Alternatively,expandable member 123 may comprise a self-expanding mechanical basket asdescribed hereinbelow with respect to FIGS. 8A-8B.

Elongated shaft 121 further comprises therapeutic ultrasound transducer124 disposed on elongated shaft 121 just proximal of distal region 122.Ultrasound transducer 124 is capable of transmitting at therapeuticultrasound frequencies. Transducer 124 preferably comprises an annularphased array, and is coupled to a transmission cable (not shown)disposed in a lumen of elongated shaft 121. The transmission cableextends proximally and is coupled to electrical connector 129 of handle128. Electrical connector 129 in turn is connected to ultrasoundgenerator/controller 131 by cable 130, as depicted in FIG. 4.

Referring now to FIG. 5, a preferred method of using apparatus 120 ofFIG. 4 is described. Atraumatic tip 132 at the distal end of elongatedshaft 121 is inserted into a patient's urethra U with expandable member123 in a contracted state. Expandable member 123 is positioned within apatient's bladder B, e.g., using measurement indica 133 of FIG. 4.Expandable member 123 then is deployed and handle 128 is retractedproximally so that expandable member 123 is anchored against bladderoutlet O. In accordance with the present invention, retractingexpandable member 123 against bladder outlet O positions transducer 124at a desired treatment site within urethra U using only tactilefeedback.

Ultrasound generator/controller 131 is turned on and set to the desiredfrequency to cause transducer 124 to emit ultrasonic beams. Ultrasoundbeams 126 are focused to cause a rise in tissue temperature at a desireddistance beneath mucosal layer M of urethra U. The heating of thedesired submucosal tissue causes localized denaturation of the tissue.The change in submucosal tissue created by the denaturation andrenaturation of the collagen results in changes in tissue compliance ofthe urethral wall and/or bladder outlet, thereby reducing urinaryincontinence.

Referring now to FIGS. 6-7, a further alternative embodiment of thepresent invention is described whereby cryogenic therapy is used totreat urinary incontinence by controlled freezing of selected urethraltissue.

In FIG. 6A, cryogenic therapy apparatus 140 comprises elongated shaft142 having proximal and distal ends and reduced diameter distal region144 disposed adjacent to the distal end. Handle 141 is coupled to theproximal end of elongated shaft 142 and may comprise inflation port 159that is in fluid communication with expandable member 145,illustratively a balloon. Alternatively, expandable member 145 maycomprise a self-expanding mechanical basket as described hereinbelowwith respect to FIGS. 8A-8B.

Apparatus 140 further comprises at least one hollow needle 143 andcryogenic probe 152. Needle 143 has proximal and distal ends andsharpened tip 147 disposed at the distal end. The proximal end of eachhollow needle 143 is coupled to knob 146. Although four hollow needlesare illustrated in FIG. 6C, it will be apparent to those skilled in theart that greater or fewer needles may be used.

Handle 141 further comprises proximal port 150 having at least one probeinsertion hypotube 151, as depicted in FIG. 6B. Each probe insertionhypotube 151 corresponds to a respective needle 143. Each probeinsertion hypotube 151 comprises an outer diameter that preferably isslightly smaller than an inner diameter of hollow needle 143. A proximalend of each probe insertion hypotube 151 is affixed to proximal port 150while a distal end of each hypotube 151 extends into the proximal end ofits respective hollow needle 143 to create an overlap between the distalend of the hypotube and the proximal end of the needle, as shown in FIG.6C. This overlap allows needles 143 to move with respect to probeinsertion hypo tubes 151 when knob 146 is actuated.

Cryogenic probe 152 has proximal and distal ends and tip 153 disposed atthe distal end. Handle 154 is coupled to the proximal end of cryogenicprobe 152 and is configured to be grasped by a physician. Cryogenicprobe 152 is powered and controlled by cryogenic generator 156 via wire155, which is coupled to handle 154. Cryogenic probe 152 comprises anouter diameter configured to be inserted into probe insertion hypotube151 and through hollow needle 143.

Referring now to FIG. 7, a preferred method of using apparatus 140 ofFIG. 6A to treat urinary incontinence is described. Atraumatic tip 157at the distal end of elongated shaft 142 is inserted into a patient'surethra U with needle 143 in a contracted state, i.e., retracted withinthe confines of elongated shaft 142, and also with expandable member 145provided in a contracted state. Expandable member 145 is positionedwithin a patient's bladder B, e.g., using measurement indica 158.Expandable member 157 then is deployed within bladder B and handle 141is retracted proximally so that expandable member 157 is anchoredagainst bladder outlet O. In accordance with one aspect of the presentinvention, retracting expandable member 157 against bladder outlet Opositions needle 143, when deployed, at a desired treatment site withinurethra U using only tactile feedback.

Needle 143 then is actuated by distally advancing knob 146, which urgesneedle 143 to extend beyond elongated shaft 142, pierce mucosal layer Mof urethra U, and extend into submucosal layer S. Needle 143 preferablycomprises a shape-memory material that causes the distal end to curve toa predetermined shape when needle 143 is no longer confined withinelongated shaft 142.

Cryogenic probe 152 then is inserted into probe insertion hypotube 151at proximal port 150 and is advanced distally via probe insertionhypotube 151 into hollow needle 143. Cryogenic probe 152 is advanceddistally until it extends distal of needle 143 and into submucosal layerS of the urethra, as shown in FIG. 7. Needle 143, having a largerdiameter relative to probe 152, serves to dilate the submucosal tissueprior to insertion of the probe so that the probe encounters reducedresistance from the tissue.

Cryogenic generator 156 is turned on and set to the desired temperature,which preferably is between about −80° F. and −110° F., to cause localregions of the submucosal tissue to freeze. The local regions of tissueand tip 153 may freeze together for about three minutes, after whichtime probe 152 is defrosted and removed from within elongated shaft 142and handle 141. If desired, a physician then may re-insert probe 152into a different insertion hypotube 151 and the procedure may berepeated through a different needle 143 to treat another region withinsubmucosal layer S. In accordance with principles of the presentinvention, the application of cryogenic probe 152 to the submucosaltissue causes small localized regions of submucosal tissue to undergonecrosis, after which tissue healing ensues. This results in alteredtissue elasticity, tensile strength, and tissue compliance in theurethra and/or bladder outlet, and causes a significant improvement inurinary incontinence.

Referring now to FIGS. 8A-8B, an alternative expandable member isdescribed for use with any of the treatment techniques describedhereinabove. Apparatus 170 comprises self-expandable basket 172, shownin a deployed state in FIG. 8B, instead of a balloon. Basket 172preferably comprises a plurality of flexible struts 171 joined to rod176 via hinges 180. Struts 171, which may be covered by a biocompatibleelastomeric membrane (not shown), are constrained in a contractedposition within central lumen 177 of elongated shaft 181, as illustratedin FIG. 8A. Struts 171, which preferably comprise a shape-memorymaterial such as Nitinol, assume a predetermined curvature extendingradially outward from elongated shaft 181 in the deployed state, i.e.,when struts 171 are no longer effectively constrained within centrallumen 177, as shown in FIG. 8B.

Rod 176 has proximal and distal ends and is disposed through centrallumen 177. Preferably, rod 176 includes atraumatic distal tip 178disposed at the distal end. The proximal end of rod 176 is configured tobe manipulated by a physician.

In operation, atraumatic tip 178 and elongated shaft 181 are insertedinto the patient's urethra in a manner described hereinabove. Oncedistal end 184 of elongated shaft 181 is positioned within a patient'sbladder, the proximal end of rod 176 is advanced distally by a physicianto self-deploy mechanically expandable basket 172, as depicted in FIG.8B. Once basket 172 is deployed within the bladder, elongated shaft 181and rod 176 are retracted proximally to cause basket 172 to becomeanchored against the bladder outlet.

At this time, needles 183 may be deployed from elongated shaft 181 topenetrate the urethral wall to perform a radio frequency treatment ofthe tissue. Alternatively, needles 183 may be omitted and needlelessradio frequency waves or ultrasound beams may be used to treatincontinence, as described hereinabove.

After the preferred treatment is completed, basket 172 is returned tothe contracted configuration by retracting rod 176 proximally withrespect to elongated shaft 181 to cause struts 171 to be containedwithin central lumen 177.

Referring now to FIGS. 9-10, apparatus and methods for longitudinallyadvancing the spacing between the tissue treating elements and theexpandable member are described. In FIG. 9, apparatus 200 is provided inaccordance with apparatus 20 of FIG. 1, except as noted below. Apparatus200 comprises handle 202 and knob 204, which are similar in structure tohandle 31 and knob 57 of FIG. 1, respectively.

Apparatus 200 further comprises elongated shaft 206 having proximal anddistal ends and actuator 214 disposed about the proximal end.Measurement indica 212 preferably are provided on a lateral surface ofelongated shaft 206. Illustratively, needle electrodes 210 are shown forproviding energy to the submucosal layer of the urethral wall, althoughit will be apparent that needleless electrodes, an ultrasound transduceror cryogenic probe, as described hereinabove, may be substituted forneedle electrodes 210.

Apparatus 200 further comprises shaft 208 having proximal and distalends and expandable member 209 disposed on the distal end. Shaft 208preferably is affixed to an interior surface of handle 202 and mayinclude inflation lumen 220 extending between the proximal and distalends that communicates with expandable member 209.

Referring now to FIG. 10A, a side sectional view of the distal end ofapparatus 200 is provided. Elongated shaft 206 preferably comprisescentral lumen 217 having an inner diameter slightly larger than an outerdiameter of expandable member shaft 208. Inflation lumen 220 is in fluidcommunication with expandable member 209, while lumens 218 house needleelectrodes 210 in the contracted state (see FIG. 10A).

Region 222 of shaft 208 may be threaded to provide threaded interface219 between shaft 208 and central lumen 217 of elongated shaft 206, asshown in FIG. 10B. Threaded interface 219 provides for controlledlongitudinal movement of elongated shaft 206 with respect to shaft 208when actuator 214 of FIG. 9 is rotated circumferentially.

Referring to FIG. 10C, the threaded interface between elongated shaft206 and shaft 208 is omitted and small gap 227 is provided betweencentral lumen 217 and shaft 208. Gap 227 allows for straight translationof elongated shaft 206 with respect to shaft 208 when actuator 214 islongitudinally advanced and handle 202 is held stationary.

Using the technique of FIGS. 9-10, a physician may perform a firsttreatment at a distance of about x₁ from the bladder outlet, as shown inFIG. 10A, assuming that expandable member 209 is disposed within thebladder and then retracted against the bladder outlet. The physicianthen may perform a second treatment at a distance of about x₂ from thebladder outlet by actuator 214 as described hereinabove. Measurementindica 212 may be used as a distance guide when a physician manipulatesthe distance between x₁ and x₂ using actuation handle 214.

Referring now to FIG. 11, an alternative embodiment of apparatusconfigured to longitudinally advance the spacing between the tissuetreating elements and the expandable member is described. In FIG. 11,apparatus 200′ is provided substantially in accordance with apparatus200 of FIGS. 9-10, except as noted below.

In the embodiment of FIG. 11, shaft 208′ extends through elongated shaft206′ and preferably is coupled to actuator 250 instead of being affixedto an interior surface of handle 202′, as described in the embodiment ofFIGS. 9-10. Actuator 250 may be disposed about handle 202′ in a mannersimilar to the manner in which knob 57 of FIG. 1 is disposed abouthandle 31, as described hereinabove. Alternatively, actuator 250 may bedisposed proximal of handle 202′. For example, shaft 208′ may extendthrough handle 202′, through an aperture or port (not shown) disposed atthe proximal end of handle 202′, and then may be coupled to actuator 250proximal of the handle.

Apparatus 200′ may comprise a threaded interface between shaft 208′ anda central lumen of elongated shaft 206′, as described in FIG. 10Bhereinabove. The threaded interface provides for controlled longitudinalmovement of shaft 208′ with respect to elongated shaft 206′ whenactuator 250 is rotated circumferentially and handle 202′ is heldstationary.

Alternatively, a small gap, such as described hereinabove with respectto FIG. 10C, may be provided between the central lumen of elongatedshaft 206′ and shaft 208′. This permits straight translation of shaft208′ with respect to elongated shaft 206′ when actuator 250 is advancedor retracted and handle 202′ is held stationary. Measurement indica (notshown) may be disposed on handle 202′ or shaft 208′ to determine thespacing between tissue treating elements 210′ and expandable member209′.

Handle 202′ also may comprise a central lumen, e.g., as describedhereinabove with respect to FIGS. 10B-10C, that guides shaft 208′through handle 202′. The central lumen of handle 202′ may be used aloneor in conjunction with the central lumen of elongated shaft 206′ toserve as a guide for shaft 208′ along the length of the device.

While preferred illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from theinvention. The appended claims are intended to cover all such changesand modifications that fall within the true spirit and scope of theinvention.

1. An apparatus for remodeling at least one treatment site within thelower urinary tract of a female patient, the lower urinary tractincluding a urethra having a urethral lumen and a bladder having abladder outlet, the apparatus comprising: an elongated shaft havingproximal and distal ends and a distal region disposed adjacent to thedistal end; a handle coupled to the proximal end; a plurality of needlesconfigured to selectively extend from within the shaft, the plurality ofneedles configured for treating a submucosal layer of the urethra orbladder outlet to cause a reduction in the compliance of the submucosallayer; and an expandable member deployable at a predetermined distancedistal of the plurality of needles, the expandable member adapted to bedeployed in the bladder and anchored against the bladder outlet, whereinthe plurality of needles does not substantially narrow the urethrallumen and bladder outlet, and wherein the expandable member comprises aself-expandable basket.
 2. The apparatus of claim 1, wherein theself-expandable basket comprises a plurality of flexible struts coupledto a rod, and wherein the rod is disposed within a central lumen of theelongated shaft.
 3. The apparatus of claim 2, wherein theself-expandable basket comprises a contracted state, in which theplurality of flexible struts are constrained within the central lumen ofthe elongated shaft, and a deployed state, in which the plurality offlexible struts assume a predetermined curvature extending radiallyoutward from the elongated shaft.
 4. The apparatus of claim 3, whereinthe plurality of flexible struts comprise a shape-memory material.
 5. Anapparatus for remodeling at least one treatment site within the lowerurinary tract of a female patient, the lower urinary tract including aurethra having a urethral lumen and a bladder having a bladder outlet,the apparatus comprising: an elongated shaft having proximal and distalends and a distal region disposed adjacent to the distal end; a handlecoupled to the proximal end; a plurality of needles configured toselectively extend from within the shaft, the plurality of needlesconfigured for treating a submucosal layer of the urethra or bladderoutlet to cause a reduction in the compliance of the submucosal layer;and an expandable member deployable at a predetermined distance distalof the plurality of needles, the expandable member adapted to bedeployed in the bladder and anchored against the bladder outlet, whereinthe plurality of needles does not substantially narrow the urethrallumen and bladder outlet, and wherein the elongated shaft furthercomprises a plurality of measurement indica suitable for use inpositioning the expandable member within the bladder.
 6. The apparatusof claim 5, wherein the expandable member comprises a balloon that isaffixed to the distal region of the elongated shaft.
 7. The apparatus ofclaim 5, further comprising at least one irrigation port disposed in alateral surface of the elongated shaft and configured to provideirrigation fluid in the vicinity of the plurality of needles.
 8. Anapparatus for remodeling at least one treatment site within the lowerurinary tract of a female patient, the lower urinary tract including aurethra having a urethral lumen and a bladder having a bladder outlet,the apparatus comprising: an elongated shaft having proximal and distalends and a distal region disposed adjacent to the distal end; a handlecoupled to the proximal end; a plurality of needles configured toselectively extend from within the shaft, the plurality of needlesconfigured for treating a submucosal layer of the urethra or bladderoutlet to cause a reduction in the compliance of the submucosal layer;and an expandable member deployable at a predetermined distance distalof the plurality of needles, the expandable member adapted to bedeployed in the bladder and anchored against the bladder outlet, whereinthe plurality of needles does not substantially narrow the urethrallumen and bladder outlet, and a cryogenic probe.
 9. The apparatus ofclaim 8, wherein at least one of the plurality of needles is hollow, andwherein the cryogenic probe is configured to be longitudinally advancedthrough the hollow needle.
 10. An apparatus for remodeling at least onetreatment site within the lower urinary tract of a female patient, thelower urinary tract including a urethra having a urethral lumen and abladder having a bladder outlet, the apparatus comprising: an elongatedshaft having proximal and distal ends and a distal region disposedadjacent to the distal end; a handle coupled to the proximal end; aplurality of needles configured to selectively extend from within theshaft, the plurality of needles configured for treating a submucosallayer of the urethra or bladder outlet to cause a reduction in thecompliance of the submucosal layer; and an expandable member deployableat a predetermined distance distal of the plurality of needles, theexpandable member adapted to be deployed in the bladder and anchoredagainst the bladder outlet, wherein the plurality of needles does notsubstantially narrow the urethral lumen and bladder outlet, and whereina distance between the means for treating and the expandable member maybe longitudinally adjusted.
 11. The apparatus of claim 10, wherein theexpandable member is disposed on a shaft, the apparatus furthercomprising a threaded interface between the shaft and a central lumen ofthe elongated shaft.
 12. The apparatus of claim 10, wherein theexpandable member is disposed on a shaft, the apparatus furthercomprising an actuator coupled to the shaft.